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Home > Scientific articles
Apr 2025

Fexinidazole as a new oral treatment for human African trypanosomiasis due to Trypanosoma brucei rhodesiense: A prospective, open-label, single-arm, Phase II–III, non-randomised study

The Lancet Global Health

by Matovu E, Nyirenda W, Eriatu A, Alves D, Perdrieu C, Lemerani M, Wamboga C, Lejon V, Seixas J, Signorell A, Reymondier A, Baudin E, Scherrer B, Valverde Mordt O. The Lancet Global Health 2025, 13(5):e910-e919. doi: 10.1016/S2214-109X(25)00016-6

Summary: Fexinidazole is a safe and effective treatment for gambiense human African trypanosomiasis (HAT). The authors of this manuscript investigated whether fexinidazole could offer an alternative to existing treatments for rhodesiense HAT (r-HAT), melarsoprol (stage 2) and suramin (stage 1). Excluding one death unrelated to r-HAT or fexinidazole, the fatality rate at end of hospitalization was 0% (90%CI 0·00-8·43) in the 35 participants with stage 2 r-HAT, which is lower than the approximated 8·5% fatality rate in patients treated with melarsoprol (p=0·0488). One participant with stage 2 r-HAT had a relapse at week 9. No failures were reported in 10 participants with stage 1 r-HAT. No unexpected safety signals were identified. Fexinidazole is a safe and easy-to-use alternative to existing treatments for r-HAT.

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